Z-0628-2014Class II

REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP...

Name: Z-0628-2014 REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP...
Creator: Materialise USA LLC
Published: 2013-11-26
License: https://open.fda.gov/license/

Materialise USA, LLC. / initiated 2013-11-26 / Terminated / root cause: manufacturing process

FDA source

Materialise USA LLC began a recall of REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA... on 2013-11-26. FDA classified it as Class II and gives the reason as "Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0628-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2014-01-03
Terminated: 2014-01-14
Recalling firm: Materialise USA, LLC.
Product: REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Materialise USA LLC notified the Field Representative on November 26, 2013 of the recall by phone followed by E-mail notification. The notification identified the device and reason for the recall. Notification directions included instructions to find and quarantine the device and return it Materialise. A replacement device was shipped November 27, 2013 receiving the defective device was called, followed by E-mail notification the Recall, which identified the device, problem, and instructed the distributor to find and quarantine product. For questions regarding this recall call 734-662-5057.
Quantity in commerce: 1
Distribution: US Distribution: MO only.
Product codes and lots: Lot 094929

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0628-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0628-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-03

Product code HRY

K110415Class IISignature Planner / Signature GuidesMaterialise NV / cleared 2011-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)